FDA’s June 2026 guide says, unless the simplified ts.xpt pathway applies, all Trial Design Model datasets should accompany each SDTM study submission to describe planned conduct.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Include the applicable Trial Design Model datasets with an SDTM study submission unless the current FDA guidance indicates the simplified ts.xpt pathway; use the current guide for relevant Trial Summary parameters.
Key details
Core IssueFDA’s June 2026 guide says, unless the simplified ts.xpt pathway applies, all Trial Design Model datasets should accompany each SDTM study submission to describe planned conduct.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Purpose
Include the applicable Trial Design Model datasets with an SDTM study submission unless the current FDA guidance indicates the simplified ts.xpt pathway; use the current guide for relevant Trial Summary parameters.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
In the June 2026 FDA Study Data Technical Conformance Guide, SDESIGN is the Trial Summary parameter code for Study Design; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, ASOCSTDY is the Trial Summary parameter code for Associated Study; FDA lists it as conditional for nonclinical Trial Summary data. FDA notes: include it if applicable. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
FDA’s June 2026 conformance guide says a custom domain should be used only after confirming the data do not fit an existing domain, with implementation described in the clinical Study Data Reviewer’s Guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STCAT is the Trial Summary parameter code for Study Category; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STDIR is the Trial Summary parameter code for Study Director; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STENDTC is the Trial Summary parameter code for Study End Date; FDA lists it as conditional for nonclinical Trial Summary data (when applicable). This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STRPSTAT is the Trial Summary parameter code for Study Report Status; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
